昆仙胶囊联合泼尼松片治疗风湿性多肌痛临床疗效

The efficacy and safety of Prednisone plus Kunxian Capsule for polymyalgia Rheumatica

目的评价昆仙胶囊治疗风湿性多肌痛(polymyalgia rheumatic,PMR)的临床疗效和安全性。方法将68例PMR病情活动患者随机分为泼尼松治疗组,昆仙胶囊+泼尼松治疗组以及甲氨蝶呤(methotrexate,MTX)+泼尼松治疗组。疗程均为12周。治疗前后与治疗期间分别检测血沉(ESR)、C反应蛋白(CRP)、血红蛋白(HGB)、血清白蛋白(ALB),并对患者病情作PMR活动指数评分(PMR-AS),比较各组上述指标,同时比较12周末各组泼尼松用量。结果昆仙胶囊+泼尼松治疗组以及MTX+泼尼松治疗组的PMR活动指数评分、ESR、CRP等指标及12周末激素剂量均显著低于泼尼松治疗组(P <0.05)。3组不良事件发生率差异无统计学意义。结论昆仙胶囊联合泼尼松对PMR病情活动患者的症状、体征及炎症指标的控制优于单用激素,可作为除MTX以外的控制PMR病情活动的免疫抑制剂。

Objective To assess the therapeutic efficacy and safety of Kunxian Capsule(KXC) in treatment of polymyalgia Rheumatica(PMR).Methods To compare the efficacy and safety of prednisone plus Kunxian capsule(KXC),Prednisone plus methotrexate(MTX) and prednisone alone in patients with PMR,68 patients of PMR were randomized assigned to three groups,i.e.KXC+Prednisone group,MTX+Prednisone group,Prednisone group,respectively.The therapeutic course for them all was 12 weeks.The measurements included ESR,CRP,HGB,and ALB as well as PMR-AS before and during the treatment.At the end of the treatment course,the prednisone dose of each group was also measured.Result KXC+Prednisone group as well as MTX+Prednisone group made better improvements on the measurements than the Prednisone group,with a statistical difference(P <0.05).The dose of prednisone in Prednisone group was statistically higher than in the other two groups(P <0.05).The rates and severity of adverse events in all three groups were similar.Conclusions KXC could relieve symptoms,improve all kinds of measures during the PMR disease course and help steroid sparing.It could be an alternative choice other than MTX in patients suffering from disease flare.